Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorFederal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

About this trial

This is a prospective, randomized study in women of reproductive age with vulvar lichen sclerosus. Participants will be randomly assigned by investigators using a computer-generated sequence to receive either combined dynamic quadripolar radiofrequency (DQRF) plus topical corticosteroid therapy or topical high-potency corticosteroid therapy alone. Clinical outcomes, patient-reported outcomes and tissue-level changes evaluated by histology, elastin histochemistry, and immunohistochemistry for estrogen, androgen receptors and superoxide dismutase 2 (SOD2) will be assessed before and after treatment, and during follow-up at 3, 6, and 12 months. Safety will be monitored throughout the study. Histochemical and immunohistochemical analyses will be performed in a subset of 10 patients per group before the treatment and at 3 months after the completion of treatment.

Eligibility criteria

Qualifiers

Women aged 18 to 49 years (women of reproductive age);

Histologically confirmed diagnosis of vulvar lichen sclerosus;

Written informed consent to participate in the study.

Disqualifiers

Pregnancy or lactation;

Malignancy at the time of treatment or during any period of follow-up;

Postmenopausal status;

Severe decompensated somatic disease;

Trial design

Treatments tested in this trial

  • Dynamic Quadripolar Radiofrequency (DQRF)
  • Topical high-potency corticosteroid

Treatment groups

68 Participants
are divided into 2 treatment groups